RecruitingPhase 3NCT05939687

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial


Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

142 participants

Start Date

Jun 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study. Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing a surgical mesh at the site where a temporary bowel opening (stoma) is closed — after surgery for rectal cancer — helps prevent a hernia from forming at that site. **You may be eligible if...** - You previously had a temporary stoma (bowel opening through the abdomen) created during rectal cancer surgery, and are now scheduled to have it closed - Your cancer has not spread to other organs - You have completed any required chemotherapy or radiation treatment - You are in reasonable general health (ECOG 0–2) - There are no current complications or infections around your stoma - Your bowel connection (anastomosis) from the original surgery is intact **You may NOT be eligible if...** - You have active cancer spread (metastases) - You have an active infection or inflammation around the stoma site - You have conditions that make mesh placement unsafe - You have not completed adjuvant treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREmesh

We'll use mesh repair for prevention of stoma-site hernias in the study group.

PROCEDUREnon-mesh

We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.


Locations(1)

N.N.Blokhin Russian Cancer Research Center

Moscow, Russia

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NCT05939687


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